# K210382: Blustone Synergy Diamond SA Cervical System

- Pathway: 510(k) (Traditional)
- Applicant: Blustone Synergy, LLC
- Decided: Jul 23, 2021 after 164 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K841189 (1984). 335 ancestors in all.
No later device cites it as a predicate yet.
1 of 336 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171893: Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate), Bluestone Synergy (2017) Summary page 5.
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 5.
- K131449: Coalition Spacer, Globus Medical, Inc. (2013) Summary page 5.
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS, Globus Medical, Inc. (2017) Summary page 5.
- K152972: Amendia Stand-Alone Cervical System, Amendia, Inc. (2016) Summary page 5.
- K202065: DOLOMITE Anterior Cervical Stabilization System, Astura Medical, LLC (2020) Summary page 5.

## Indications for use
The Blustone Synergy Diamond SA Cervical System are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy Diamond SA Cervical System may be used with additional supplemental fixation.

Source page: https://510kreport.com/device/K210382
Methodology: https://510kreport.com/methodology